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510(k) K832771

Device
ERYTHROCYTE TEST
Applicant
BIO-ANALYTICS LABORATORIES, INC.
510(k) number
K832771
Product code
LKZ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-28
Date received
1983-08-16
Regulation
864.7100
Classification name
Red-cell Count By Photometry
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEWorthington Diagnostic Systems1984-01-04

Legacy Summary#

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FDA Review#

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